tadalafil

Generic: tadalafil

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 2.5 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-247
Product ID 75834-247_45810509-9e49-3ee2-e063-6394a90aa944
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211298
Listing Expiration 2026-12-31
Marketing Start 2020-11-02

Pharmacologic Class

Established (EPC)
phosphodiesterase 5 inhibitor [epc]
Mechanism of Action
phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834247
Hyphenated Format 75834-247

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0375834248301 0375834247304 0375834250304
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tadalafil (source: ndc)
Generic Name tadalafil (source: ndc)
Application Number ANDA211298 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (75834-247-01)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-247-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (75834-247-30)
source: ndc

Packages (3)

75834-247-01 1000 TABLET, FILM COATED in 1 BOTTLE (75834-247-01) 75834-247-15 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-247-15) 75834-247-30 30 TABLET, FILM COATED in 1 BOTTLE (75834-247-30)

Ingredients (1)

tadalafil (2.5 mg/1)

Linked Drug Pages (1)

Tadalafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45810509-9e49-3ee2-e063-6394a90aa944", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0375834248301", "0375834247304", "0375834250304"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (75834-247-01)", "package_ndc": "75834-247-01", "marketing_start_date": "20201102"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (75834-247-15)", "package_ndc": "75834-247-15", "marketing_start_date": "20201102"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (75834-247-30)", "package_ndc": "75834-247-30", "marketing_start_date": "20201102"}], "brand_name": "Tadalafil", "product_id": "75834-247_45810509-9e49-3ee2-e063-6394a90aa944", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "75834-247", "generic_name": "Tadalafil", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA211298", "marketing_category": "ANDA", "marketing_start_date": "20201102", "listing_expiration_date": "20261231"}